The Medicines and Healthcare products Regulatory Agency (MHRA) is consulting on the reclassification of codeine linctus to a prescription-only medicine. Codeine linctus is an oral solution or syrup with the active ingredient codeine phosphate and is used to stop a dry cough. The consultation has been launched after considering multiple Yellow Card reports that codeine linctus is being used recreationally for its opioid effects, rather than for its intended use as a cough suppressant.
This medication is currently licensed as a pharmacy medicine, which means that it is available to purchase over the counter in pharmacies. If reclassified as a prescription-only medicine, all strengths of codeine linctus will only be available upon presentation of a prescription.
The MHRA would like to hear from a broad range of individuals for their views on this potential change in classification.
Dr Alison Cave, MHRA Chief Safety Officer, said:
Codeine linctus is an effective medicine, but as it is an opioid, its misuse and abuse can have major health consequences.
Every response received will help us to develop a broader view on whether codeine linctus should be restricted to prescription-only status.
We want to hear from members of the public, health professionals and others who would be affected by this potential change so we can make a properly considered decision for the benefit of patients, carers, and healthcare professionals across the UK.
Professor Claire Anderson, President of the Royal Pharmaceutical Society, said:
We welcome the MHRA consulting in this area, to understand the impact of this potential change on pharmacists, pharmacy teams and the public.
Medicines should maximise benefits to patient health with minimum risk. We believe there is insufficient robust evidence for the benefits of codeine linctus in treating coughs safely and appropriately. We also have significant concerns about its misuse and addictive potential, as well as the risk of overdose.
There are many non-codeine based products available for the treatment of dry cough. With studies showing up to 60% of people are genetically predisposed to opioid dependence, the role of codeine linctus in treating what is ultimately a self-limiting condition is questionable.
The MHRA welcomes views as to whether codeine linctus should become a prescription-only medicine, where access is only given based on the prescribing judgement of a GP. The MHRA is committed to ensuring the safe use of medicines, especially those that are potentially extremely addictive.
The codeine linctus consultation will run for four weeks and is open until 15 August 2023.
Additional information
- Codeine linctus is an opioid medicine which can cause addiction.
- Codeine is broken down in the body into morphine, which is thought to provide its main activity, however not everybody is able to metabolise codeine. Conversely, others may break it down much more quickly and experience significant side effects. As a result, the risk that a person could become addicted or experience toxic effects will differ between individuals.
- Codeine linctus may make a person feel dizzy and sleepy, which can influence the ability to drive safely. It is an offence to drive if codeine has affected someone's ability to drive safely.
- Codeine linctus can slow down breathing rate, cause constipation, allergic reactions, confusion and withdrawal reactions after cessation. It may also cause the person to lose sight of how much they have consumed, increasing the risk of accidental overdose.
Notes
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- This consultation will run for four weeks from 18 July 2023 to 15 August 2023.
- Since 2018, the MHRA has received 116 Yellow Card reports of recreational drug abuse, dependence and/or withdrawal to codeine medicines, including codeine linctus.
